[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04326192":3,"trial-entities:NCT04326192":81,"trial-summary:NCT04326192":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":73,"overall_officials":76,"references":79,"see_also_links":80},"NCT04326192","STUDY00020197","Brown Adipose Tissue Activation by Spinal Cord Stimulation","RECRUITING","2029-12","2026-08","2026-08-25","2021-02-19","Oregon Health and Science University","OTHER",true,"The objective of this study is to investigate and utilize spinal cord stimulation (SCS) as an effective approach to eliciting weight loss and potentially alleviating Type 2 diabetes mellitus (DM), as evidenced by increasing metabolism of adipose tissue.","This research study aims to investigate possible activation of brown adipose tissue (BAT) metabolism by upper thoracic spinal cord stimulation (SCS). We believe that our multidisciplinary research team presents a unique opportunity to test whether SCS can activate BAT metabolism, as tested during a routine screening procedure for spinal cord stimulation (SCS) for pain control. Our marker for BAT activation is 18F-fluorodeoxyglucose (FDG) - positron emission tomography (PET), which has previously been used to gauge cold-evoked BAT activation, and other studies of BAT in humans. We believe this proof-of-concept study could pave the way for a new therapeutic modality for the treatment of morbid obesity, and Type 2 Diabetes Mellitus.",[18,19,20],"Pain, Back","Obesity, Morbid","Type 2 Diabetes",[22,23],"Obesity","Diabetes","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},10,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Research electrode","An additional research electrode will be placed percutaneously by Tuohy needle in the epidural space at the same time as the SCS trial implant; at lateral T1-2 area randomly assigned to the left or right side of the lateral epidural space, at the time of the procedure. Placement of electrodes is not experimental, but the placement of an additional electrode is a research-driven procedure.",[37],"All subjects",[39],{"measure":40,"description":41,"timeFrame":42},"SUVmax","Maximum standardized uptake value (SUVmax) of bilateral cervical and supraclavicular regions during SCS activation, in comparison to baseline imaging","1 week",[44],{"measure":45,"description":46,"timeFrame":42},"Ipsi- and contralateral BAT during SCS-activation","A comparison of ipsi- and contralateral BAT during SCS-activation. PET\u002FCT images will be reconstructed as per standard clinical routine.","ALL","21 Years","70 Years",false,{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Inclusion Criteria:\n\n1. Age: 21-70 years\n2. Persistent neuropathic leg and back pain\n3. Subjects who are already planning to undergo SCS for pain\n4. Subjects who have not received a prior SCS trial for pain\n5. Subjects with a BMI of 25-45, using formula; weight (lb) \u002F \\[height (in)\\]2 x 703\n\nExclusion Criteria:\n\n1. Not considering SCS for pain\n2. Forensic patient\n3. Taking beta blockers\n4. Weight change \\> 5% within last 3 months\n5. Habitual tobacco use\n6. Habitual excessive alcohol use\n7. Pregnancy\n8. Decisionally impaired adults\n9. Children\n10. Neonates\n11. Subjects with a BMI of \\\u003C25 or \\>45",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":60,"status":7,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":70},"Oregon Health & Science University","Portland","Oregon","97239","United States",[66],{"name":67,"role":68,"phone":69},"Kim Burchiel, MD","CONTACT","503-494-4314",{"lat":71,"lon":72},45.52345,-122.67621,[74],{"name":67,"role":68,"phone":69,"email":75},"burchiek@ohsu.edu",[77],{"name":67,"affiliation":12,"role":78},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":85},[83,22,84],"Neuropathic Pain","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":14,"summary":87,"prompt_version":97},{"design":88,"status":89,"heading":90,"summary":91,"follow_up":92,"word_count":93,"commitments":94,"compensation":95,"drugs_mentioned":96},"This is an interventional study with a planned enrollment of 10 participants. It is not specified if it is randomized or blinded.","completed","Spinal Cord Stimulation for Obesity and Type 2 Diabetes","This study is exploring if spinal cord stimulation (SCS), a treatment often used for pain, can help with weight loss and Type 2 diabetes. Researchers will place a second research electrode in your upper back during your planned SCS implant procedure. They will then measure changes in your body's metabolism (how your body uses energy) after one week. This study is for people aged 21-70 who have ongoing leg and back pain, are already planning to get SCS for pain, and have a body mass index (BMI) between 25 and 45. The goal is to see if SCS can activate brown adipose tissue (BAT), a type of fat that burns calories, which could lead to new ways to treat obesity and Type 2 diabetes. The current recruitment status is unclear.","Participants will be followed for one week to measure the primary endpoint.",130,"You would have a second research electrode placed during your planned spinal cord stimulator (SCS) implant procedure. Your metabolism will be measured after one week using a PET scan.","Not stated in the trial record.",[34],"v2"]